Data / Medical devices / United States / Scantibodies Laboratory Inc.
Scantibodies Laboratory Inc.: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Scantibodies Laboratory Inc. is registered with the FDA (registration 3026664926) in San Diego, CA, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 2003. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3026664926
- Address
- 8005 Saint Andrews Ave, San Diego, CA, United States, 92154
- Owner or operator
- Scantibodies Laboratory Inc. (2020808)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 25, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | GNX | 1 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Campylobacter Spp. | LQP | 1 | Contract manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer | accessdata.fda.gov |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Contract manufacturer | accessdata.fda.gov |
| Reagents, Clostridium Difficile Toxin | LLH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2003 | K030258 | FIRST RESPONSE PREGNANCY TEST | LCX | Substantially Equivalent | Armkel, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Container, Specimen, Non-Sterile
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Devices Detecting Influenza A, B, And C Virus Antigens
- All makers of Reagents, Clostridium Difficile Toxin
- All makers of Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Updated February 25, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.